View clinical trials related to Nasolabial Fold.
Filter by:The aim of this study is to evaluate the efficacy and safety of the investigational device, RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold. Study hypothesis - level of significance: alpha=0.05( two-side) - power of test: (power= 1-beta),power=0.08 - H0: P equals P0 - H1: P unequals P0 - The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)
This study design is a randomized, multi-center, double Masked, matched Pairs, active-controlled clinical trial. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subeject diary and follow up visits.